Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism
Hypogonadism, Kallmann Syndrome
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring Male reproduction hormones, Hypogonadotropic hypogonadism, FSH, LH, GnRH
Eligibility Criteria
Inclusion Criteria no history of spontaneous puberty clinical hypogonadism infantile testes (< 3 ml) no reproductive hormone therapy except testosterone Complete absence of normal LH pulses during 12-hour baseline frequent blood sampling and serum testosterone < 100 ng/dl Normal testing of the anterior pituitary gland Negative MRI of the hypothalamic-pituitary area Exclusion Criteria Prior therapy with gonadotropins (FSH, hCG, or GnRH)
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group 1 (FSH)
Group 2 (GnRH)
Patients in Group 1 will receive subcutaneous follicle stimulating hormone (FSH) injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive gonadotropin releasing hormone (GnRH) therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
Patients in Group 2 will receive gonadotropin releasing hormone (GnRH) therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.